QSYMIA Drug Patent Profile

When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus Llc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in seventeen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qsymia

A generic version of QSYMIA was approved as phentermine hydrochloride; topiramate by ACTAVIS LABS FL INC on June 25^th, 2024.

Summary for QSYMIA

International Patents:	40
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	17
Patent Applications:	449
Drug Prices:	Drug price information for QSYMIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QSYMIA
What excipients (inactive ingredients) are in QSYMIA?	QSYMIA excipients list
DailyMed Link:	QSYMIA at DailyMed

See drug prices for QSYMIA

Recent Clinical Trials for QSYMIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novo Nordisk A/S	Phase 4
VIVUS LLC	Phase 4
Alvogen Korea	Phase 4

See all QSYMIA clinical trials

Pharmacology for QSYMIA

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Appetite Suppression Decreased Central Nervous System Disorganized Electrical Activity Increased Sympathetic Activity

Paragraph IV (Patent) Challenges for QSYMIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QSYMIA	Extended-release Capsules	phentermine hydrochloride; topiramate	3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg	022580	1	2013-07-18

US Patents and Regulatory Information for QSYMIA

QSYMIA is protected by six US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes			Y
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes			Y
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No

Expired US Patents for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012

International Patents for QSYMIA

When does loss-of-exclusivity occur for QSYMIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

Portugal

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QSYMIA around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2317997
China	102112127	Escalating dosing regimen for effecting weight loss and treating obesity
Canada	2727319	COMPOSITION DE TOPIRAMATE/PHENTERMINE A FAIBLE DOSE ET SES PROCEDES D'UTILISATION (LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF)
Germany	60035870

Supplementary Protection Certificates for QSYMIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	CR 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
2317997	CA 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212

Market Dynamics and Financial Trajectory for QSYMIA (Phentermine-Topiramate)

Introduction to QSYMIA

QSYMIA, a combination of phentermine and topiramate, is a leading non-injectable branded weight loss medication in the U.S. for adults. It is indicated for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight in certain adults and pediatric patients aged 12 years and older[2][4].

Mechanism of Action and Clinical Development

QSYMIA works through the synergistic effects of its two active ingredients: phentermine, a sympathomimetic amine anorectic, and topiramate, an antiepileptic drug. Phentermine suppresses appetite, while topiramate enhances the effect by reducing hunger and increasing feelings of fullness. Clinical trials have demonstrated significant weight loss and improvements in associated health conditions such as blood pressure and glycemic control[3][4].

Regulatory Milestones

The FDA approved QSYMIA in 2012, marking the second approval of an anti-obesity agent in over a decade. Recently, the FDA approved a labeling update for QSYMIA, removing specific BMI requirements and certain warnings related to heart rate, hypoglycemia, and hypotension. This update is expected to expand the patient eligibility for the medication[2].

Market Assessment

Market Outlook

The market for obesity treatments is poised for significant growth due to increasing healthcare spending and extensive research in the field. QSYMIA is expected to remain a key player, but it will face competition from emerging therapies. The forecasted sales data from 2022 to 2032 indicates a steady market presence for QSYMIA, with detailed analyses provided for the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan[1][4].

Country-Wise Market Analysis

• United States: QSYMIA is the leading non-injectable branded weight loss medication in the U.S. and is covered by 81% of commercial healthcare plans. The new label update is expected to increase its market reach[2].
• EU5 and Japan: The drug is approved and available in several European countries and Japan, with anticipated approvals in additional European and Middle Eastern countries. This expansion will contribute to its global market presence[2][4].

Financial Trajectory

Forecasted Sales

The forecasted sales data for QSYMIA from 2022 to 2032 shows a promising financial trajectory. The report provides detailed market size forecasts for each of the 7MM (seven major markets) countries, which will help clients in decision-making regarding their therapeutic portfolios[1][4].

Market Size Projections

• United States: The market size for QSYMIA in the U.S. is expected to grow steadily, driven by its established presence and the recent label update.
• EU5: Countries such as Germany, France, Italy, Spain, and the United Kingdom will see significant market growth as QSYMIA gains more approvals and penetrates these markets.
• Japan: The Japanese market is also expected to contribute substantially to the overall revenue of QSYMIA[1][4].

Competitive Landscape

QSYMIA faces competition from both existing and emerging therapies in the obesity treatment market. Other branded and generic weight loss medications, as well as new therapies in late-stage development, will challenge QSYMIA's market dominance. However, QSYMIA's proven efficacy and the recent label update position it strongly against competitors[2][4].

Emerging Therapies and Market Competition

The obesity treatment market is witnessing the development of novel therapies that could potentially compete with QSYMIA. These emerging therapies focus on new mechanisms of action and may offer alternative treatment options, thereby influencing the market dynamics. The launch of late-stage emerging therapies will significantly impact the market and could challenge QSYMIA's market share[1][4].

SWOT Analysis

Strengths

• Proven efficacy in clinical trials.
• Wide coverage by commercial healthcare plans.
• Recent label update expanding patient eligibility.

Weaknesses

• Potential side effects and safety concerns.
• Dependence on regulatory approvals in new markets.
• Competition from emerging therapies.

Opportunities

• Expanding into new markets in Europe and the Middle East.
• Increasing healthcare spending on obesity treatments.
• Growing demand for effective weight loss medications.

Threats

• Regulatory challenges and changes in healthcare policies.
• Competition from new and existing therapies.
• Economic uncertainties affecting healthcare spending[4].

Key Takeaways

• QSYMIA is a leading weight loss medication with a strong market presence in the U.S. and expanding globally.
• The recent label update is expected to increase its market reach and patient eligibility.
• The drug faces competition from emerging therapies but remains a significant player in the obesity treatment market.
• Forecasted sales data indicate a steady financial trajectory for QSYMIA from 2022 to 2032.

FAQs

1. What is QSYMIA, and how does it work? QSYMIA is a combination of phentermine and topiramate, working synergistically to suppress appetite and reduce hunger, aiding in weight loss.

2. What is the significance of the recent label update for QSYMIA? The recent label update removes specific BMI requirements and certain warnings, expanding patient eligibility and potentially increasing its market reach.

3. How does QSYMIA compare to other weight loss medications? QSYMIA is the leading non-injectable branded weight loss medication in the U.S., with proven efficacy in clinical trials, but it faces competition from emerging therapies.

4. What are the forecasted sales projections for QSYMIA from 2022 to 2032? The forecasted sales data indicate a steady market presence for QSYMIA, with detailed analyses provided for the 7MM countries.

5. Which regions are expected to contribute significantly to QSYMIA's market growth? The U.S., EU5 countries, and Japan are expected to be key contributors to QSYMIA's market growth, with additional approvals anticipated in other European and Middle Eastern countries.

Sources

1. ResearchAndMarkets.com: "QSYMIA (Phentermine - topiramate), Drug Insight and Market Forecast - 2032"
2. BioSpace: "VIVUS Announces Label Update for QSYMIA"
3. FDA: "CLINICAL REVIEW - Qsymia"
4. PR Newswire: "QSYMIA (Phentermine-Topiramate) Drug Insights and Market Forecasts to 2032"

Last updated: 2024-12-16